IGBA Urges FDA to Waive the Requirement for Bridging Studies for Biosimilar Sponsors

In a letter to FDA last month, the International Generic and Biosimilar Medicines Association (IGBA), which represents member pharmaceutical companies from the USA, Canada, South Africa, India, Jordan, Japan, Europe and Taiwan, requested that FDA “revisit their position and waive the requirement of bridging studies.” Typically, biosimilar sponsors are required to justify the relevance of comparative data using a product approved by a foreign regulatory authority and establish an acceptable “bridge” to the US-licensed reference product. The necessity of such bridging studies is currently at the discretion of FDA. Arguing that the bridge between a US-licensed reference product and the non-US reference comparator can be established by the applicant “in most cases without bridging studies, while remaining within the regulatory biosimilars framework,” IGBA urged that FDA consider a new regulatory framework utilizing the concept of a “global comparator product” and, thus, avoiding the need for expensive repetition of studies across multiple comparator products in separate jurisdictions.

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